Bausch + Lomb Announces Publication of MIEBO™ (perfluorohexyloctane ophthalmic solution) Phase 3 Extension Trial Data in Cornea

 MIEBO is the First and Only Prescription Eye Drop that Directly Targets Tear Evaporation, the Leading Cause of Dry Eye Disease

VAUGHAN, Ontario, Nov. 7, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that Cornea has published results from the KALAHARI phase 3 extension trial, which assessed the long-term safety and efficacy of MIEBO in the treatment of signs and symptoms of dry eye disease (DED). MIEBO became commercially available in September 2023.

"The results from the KALAHARI study reinforce MIEBO as a well-tolerated and effective treatment option to help provide long-term relief for patients with chronic dry eye disease,” Andrew Stewart, president, Global Pharmaceuticals and International Consumer, Bausch + Lomb.

The phase 3, multicenter, single-arm, open-label extension study evaluated the long-term safety and efficacy of MIEBO in 208 patients 18 years of age and older who had signs and symptoms of DED associated with Meibomian gland dysfunction (MGD), and who completed the randomized, double-masked, hypotonic saline-controlled phase 3 trial (GOBI). During the trial, participants administered one drop of MIEBO four times daily in both eyes for 52 weeks.

Key points from the trial:

  • Patients from GOBI who participated in the KALAHARI study showed sustained efficacy over the entire 52-week study
    • MIEBO maintained improvements in total corneal fluorescein staining (tCFS) and visual analog scale (VAS) eye dryness observed in GOBI (mean [SD] change from GOBI study baseline at week 52: -2.1 [2.5] in tCFS score and -33.7 [28.6] in VAS dryness score).
    • Patients treated with saline in GOBI who switched to MIEBO treatment in KALAHARI showed improvements in tCFS and VAS scores by week four.  
  • MIEBO was found to be well-tolerated. There were no serious ocular adverse events (AEs).
    • The most common ocular adverse reactions which may have been due to treatment were blurred vision (1.4%), allergic conjunctivitis (1.4%) and increased lacrimation (1.4%).

“With the chronic nature of dry eye disease, tolerability is a critical measure for long-term use and patient adherence,” said Eugene Protzko, M.D., lead clinical investigator of the KALAHARI study and ophthalmologist and cataract surgeon, Seidenberg Protzko Eye Associates, Havre de Grace, MD. “A single ingredient, water and preservative-free prescription eye drop, MIEBO was well-tolerated through the duration of KALAHARI, which is consistent with what we observed in the previous shorter-term studies.”

The U.S. Food and Drug Administration (FDA) approved MIEBO in May 2023, based on consistent results from two pivotal phase 3 trials. Its clinical development program included the first and only phase 3 studies for any FDA-approved prescription DED product composed entirely of patients with both DED and clinical signs of MGD. MGD is a major cause of DED development and progression, with approximately 86% of people with DED having excessive tear evaporation associated with MGD.1 DED affects more than 38 million Americans and is one of the most common ocular surface disorders.2

For more information on MIEBO, visit www.MIEBO.com.

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INDICATION

MIEBO™ (perfluorohexyloctane ophthalmic solution) is used to treat the signs and symptoms of dry eye disease.

IMPORTANT SAFETY INFORMATION

  • Patients should remove contact lenses before using MIEBO and wait for at least 30 minutes before reinserting.
  • It is important for patients to use MIEBO exactly as prescribed.
  • It is not known if MIEBO is safe and effective in children under the age of 18.
  • The most common eye side effect seen in studies was blurred vision (1% to 3 % of patients reported blurred vision and eye redness).

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information for MIEBO.

About Dry Eye Disease
DED is a chronic inflammatory ocular surface disease that is commonly characterized by dryness, stinging, burning, grittiness and/or episodes of blurred vision.3,4 The two main types of dry eye disease are aqueous deficient and evaporative. Aqueous-deficient dry eye occurs when the eyes do not produce enough tears. Evaporative dry eye is due to a deficient tear film lipid layer. The most common type of dry eye is evaporative.1

About MIEBO Phase 3 Clinical Trials
FDA approval of MIEBO was based on results from two 57-day, multi-center, randomized, double-masked saline-controlled studies, GOBI and MOJAVE. The studies assessed a total of 1,217 patients who received MIEBO or hypotonic saline (0.6%) in a 1:1 ratio.5,6

In these studies, MIEBO met both primary sign and symptom efficacy endpoints. The two primary endpoints were change from baseline at week eight (day 57 ± 2) in tCFS and eye dryness VAS score. Patients experienced relief of symptoms as early as day 15 and through day 57 with statistically significant reduction in VAS eye dryness score favoring MIEBO observed in both studies. Additionally, at days 15 and day 57, a significant reduction in tCFS favoring MIEBO was observed in both studies.

The most common adverse reactions experienced with MIEBO was blurred vision (1% to 3% of patients reported blurred vision and eye redness).

About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Twitter, LinkedIn, Facebook and Instagram.

Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

References

  1. Lemp, MA, Crews, LA, Bron AJ. (2012). Distribution of Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based Cohort: a retrospective study. Cornea, 31(5), 472-478. 2012;31(5):472-478. doi:10.109/ICO.0b013e318225415a.
  2. Downs P. 2020 Dry Eye Products Market Report: A Global Analysis for 2019 to 2025. Market Scope; 2020.
  3. Dana R, Bradley JL, et al. Estimated prevalence and incidence of dry eye disease on coding analysis of a large, all-age United States health care system. Am J Ophthalmol. 2019;202:47-54. doi:10.1016/j.ajo.2019.01.026.
  4. Dana R, Meunier J, Markowitz Jt, Joseph C, Siffel C. Patient-reported burden of Dry Eye disease in the United States: Results of an online cross-sectional survey. Am J Ophthalmol. 2020;216,7-17. doi:10.1016/j.ajo.2020.03.044.
  5. Tauber J, Berdy GJ, Wirta DL, et al. NOV03 for dry eye disease associated with meibomian gland dysfunction: Results of the Randomized Phase 3 GOBI Study. Ophthalmology. 2023;130(5):516-524. doi:10.1016/j.ophtha.2022.12.021.
  6. Sheppard J, Kurata F, Epitropoulos AT, et al. NOV03 for signs and symptoms of dry eye disease associated with meibomian gland dysfunction: The randomized phase 3 Mojave study. American Journal of Ophthalmology. 2023;252:265-274. doi:10.1016/j.ajo.2023.03.008.

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